510(k) · Cleared
ClearedPolarcup Dual Mobility System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Plus Orthopedics AG · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on Apr 16, 2007 as substantially equivalent to K991990 (Biomet, Inc., 1999) after a 77-day review. Its family tree reaches back 1 generation to 1999. 78 later devices descend from it.
- Decided
- Apr 16, 2007
- Review
- 77 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K991990 (1999). 78 later devices descend from it, 8 citing it directly.
- Root · 1 generation backK991990 Tri-Polar SystemBiomet, Inc. · 1999
- This deviceK070278 Polarcup Dual Mobility SystemPlus Orthopedics AG · 2007
- Descendant · cites it directly · 59 of its ownK083116 Versafit Cup Double Mobility SystemMedacta International S.A. · 2009 · Recalled
- Descendant · cites it directly · 27 of its ownK111572 Novae Sunfit TH Dual Mobility Acetabular Cup Model Sunfit TH…Serf · 2011 · Recalled
- Descendant · 2 generations on · 24 of its ownK101336 E1 Avantage HeadBiomet Manufacturing Corp · 2011 · Recalled
- Descendant · 2 generations on · 23 of its ownK092265 Vesafitcup Double Mobility- Highcross Hxuhmwpe LinersMedacta International S.A. · 2010
- Descendant · 3 generations on · 22 of its ownK110555 Arcomxl Active ArticulationBiomet Manufacturing Corp · 2011 · Recalled
Showing 5 of 78 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 78 · See all- K083116Versafit Cup Double Mobility SystemMedacta International S.A. · 2009 · cites it directly59descendants
- K111572Novae Sunfit TH Dual Mobility Acetabular Cup Model Sunfit TH (Metal-Back), Novae E TH…Serf · 2011 · cites it directly27descendants
- K101336E1 Avantage HeadBiomet Manufacturing Corp · 2011 · 2 generations on24descendants
- K092265Vesafitcup Double Mobility- Highcross Hxuhmwpe LinersMedacta International S.A. · 2010 · 2 generations on23descendants
- K110555Arcomxl Active ArticulationBiomet Manufacturing Corp · 2011 · 3 generations on22descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K991990 | Tri-Polar System | Biomet, Inc. | 1999 | — |
| 0 (this device) | K070278 | Polarcup Dual Mobility System | Plus Orthopedics AG | 2007 | — |
| +1 | K083116 | Versafit Cup Double Mobility System | Medacta International S.A. | 2009 | 2 |
| +1 | K111572 | Novae Sunfit TH Dual Mobility Acetabular Cup Model Sunfit TH (Metal-Back)… | Serf | 2011 | 5 |
| +2 | K101336 | E1 Avantage Head | Biomet Manufacturing Corp | 2011 | 1 |
| +2 | K092265 | Vesafitcup Double Mobility- Highcross Hxuhmwpe Liners | Medacta International S.A. | 2010 | — |
| +3 | K110555 | Arcomxl Active Articulation | Biomet Manufacturing Corp | 2011 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 7 | 0 |
| 2012 | 5 | 0 |
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 4 | 0 |
| 2019 | 6 | 0 |
| 2020 | 1 | 0 |
| 2021 | 7 | 0 |
| 2022 | 5 | 0 |
| 2023 | 6 | 0 |
| 2024 | 8 | 0 |
| 2025 | 10 | 0 |
| 2026 | 5 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LPH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LPH device
- #1 K233498 Stryker Orthopaedics Hip Systems Labeling Updatescore 24.2 · 20 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K991990 | Tri-Polar SystemSummary page 1…cemented or uncemented prosthesis; Product Code: KWY D.3 Substantial Equivalence Claimed to Predicate Device Biomet® Tni-Polar Systems, K991990 Traditional 510(k) - POLARCUP® Dual Mobility System January 23, 2007 D.4 Device Description… | 1999 |
What descends from it? (78)
See all 788 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K083116 | Versafit Cup Double Mobility System | 2009 | 59 |
| K111572 | Novae Sunfit TH Dual Mobility Acetabular Cup Model Sunfit TH (Metal-Back), Novae E TH… | 2011 | 27 |
| K110135 | Polarcup Dual Mobility System | 2011 | 14 |
| K171934 | Birmingham Hip (BH) Dual Mobility Insert | 2017 | 9 |
| K211176 | Smith & Nephew Hip Systems | 2022 | 3 |
| K181491 | Delta Dual Mobility System | 2019 | 0 |
| K123598 | Smith & Nephew, Inc. Hip System Instrumentation | 2013 | 0 |
| K111981 | Tregor Dual Mobility Acetabular System | 2012 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All LPH devicesLPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · LPH
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LPH
153in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LPH
4in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LPH
6,163in 2025
MAUDE reports naming product code LPH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 10 | 116 | 16 | 509 |
| 2008 | 10 | 86 | 1 | 706 |
| 2009 | 3 | 112 | 2 | 1,156 |
| 2010 | 15 | 100 | 22 | 2,007 |
| 2011 | 16 | 110 | 26 | 3,320 |
| 2012 | 25 | 76 | 30 | 3,785 |
| 2013 | 11 | 135 | 9 | 5,002 |
| 2014 | 20 | 129 | 3 | 5,163 |
| 2015 | 18 | 111 | 1 | 5,830 |
| 2016 | 10 | 150 | 8 | 4,900 |
| 2017 | 12 | 121 | 14 | 5,312 |
| 2018 | 9 | 145 | 2 | 5,954 |
| 2019 | 22 | 164 | 8 | 7,130 |
| 2020 | 7 | 164 | 6 | 5,429 |
| 2021 | 8 | 410 | 4 | 5,978 |
| 2022 | 14 | 247 | 2 | 5,223 |
| 2023 | 10 | 111 | 2 | 5,345 |
| 2024 | 6 | 92 | 1 | 5,626 |
| 2025 | 12 | 153 | 4 | 6,163 |
| 2026 | 8 | 256 | 2 | — |
What is it indicated for?
The POLARCUP® Dual Mobility System is indicated for:
All forms of osteoarthritis
Dislocation risks
Progressive loss of function of the hip joint as a result of a degenerative post-traumatic or inflammatory / rheumatic destruction of the joint
Femoral head necrosis
Proximal femoral fractures (especially femoral neck)
Status following earlier operations such as osteosynthesis, intertrochanteric osteotomies, arthrodesis or failed joint replacement
The POLARCUP® Dual Mobility System is intended for cemented or press-fit application with or without flanges and pegs for general use in skeletally mature individuals undergoing surgery for rehabilitating hip joints.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070278 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070278: Polarcup Dual Mobility System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070278
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026